Adenoma detection by Endocuff-assisted versus standard colonoscopy in an organized screening program: the "ItaVision" randomized controlled trial.

BACKGROUND: The Endocuff Vision device (Arc Medical Design Ltd., Leeds, UK) has been shown to increase mucosal exposure, and consequently adenoma detection rate (ADR), during colonoscopy. This nationwide multicenter study assessed possible benefits and harms of using Endocuff Vision in a fecal immunochemical test (FIT)-based screening program. METHODS: Patients undergoing colonoscopy after a FIT-positive test were randomized 1:1 to undergo Endocuff-assisted colonoscopy or standard colonoscopy, stratified by sex, age, and screening history. Primary outcome was ADR. Secondary outcomes were ADR stratified by endoscopists' ADR, advanced ADR (AADR), adenomas per colonoscopy (APC), withdrawal time, and adverse events. RESULTS: 1866 patients were enrolled across 13 centers. After exclusions, 1813 (mean age 60.1 years; male 53.8 %) were randomized (908 Endocuff Vision, 905 standard colonoscopy). ADR was significantly higher in the Endocuff Vision arm (47.8 % vs. 40.8 %; relative risk [RR] 1.17, 95 % confidence interval [CI] 1.06-1.30), with no differences between arms regarding size or morphology. When stratifying for endoscopists' ADR, only low detectors (ADR < 33.3 %) showed a statistically significant ADR increase (Endocuff Vision 41.1 % [95 %CI 35.7-46.7] vs. standard colonoscopy 26.0 % [95 %CI 21.3-31.4]). AADR (24.8 % vs. 20.5 %, RR 1.21, 95 %CI 1.02-1.43) and APC (0.94 vs. 0.77; P  = 0.001) were higher in the Endocuff Vision arm. Withdrawal time and adverse events were similar between arms. CONCLUSION: Endocuff Vision increased ADR in a FIT-based screening program by improving examination of the whole colonic mucosa. Utility was highest among endoscopists with a low ADR.

Faecal haemoglobin concentration among subjects with negative FIT results is associated with the detection rate of neoplasia at subsequent rounds: a prospective study in the context of population based screening programmes in Italy.

OBJECTIVE: To estimate the predictive role of faecal haemoglobin (f-Hb) concentration among subjects with faecal immunochemical test (FIT) results below the positivity cut-off for the subsequent risk of advanced neoplasia (AN: colorectal cancer-CRC-or advanced adenoma). DESIGN: Prospective cohort of subjects aged 50-69 years, undergoing their first FIT between 1 January 2004 and 31 December 2010 in four population-based programmes in Italy. METHODS: All programmes adopted the same analytical procedure (OC Sensor, Eiken Japan), performed every 2 years, on a single sample, with the same positivity cut-off (20 µg Hb/g faeces). We assessed the AN risk at subsequent exams, the cumulative AN detection rate (DR) over the 4-year period following the second FIT and the interval CRC (IC) risk following two negative FITs by cumulative amount of f-Hb concentration over two consecutive negative FITs, using multivariable logistic regression models and the Kaplan-Meier method. RESULTS: The cumulative probability of a positive FIT result over the subsequent two rounds ranged between 7.8% (95% CI 7.5 to 8.2) for subjects with undetectable f-Hb at the initial two tests (50% of the screenees) and 48.4% (95% CI 44.0 to 53.0) among those (0.7% of the screenees) with a cumulative f-Hb concentration ≥20 µg/g faeces. The corresponding figures for cumulative DR were: 1.4% (95% CI 1.3 to 1.6) and 25.5% (95% CI 21.4 to 30.2) for AN; 0.17% (95% CI 0.12 to 0.23) and 4.5% (95% CI 2.8 to 7.1) for CRC. IC risk was also associated with cumulative f-Hb levels. CONCLUSION: The association of cumulative f-Hb concentration with subsequent AN and IC risk may allow to design tailored strategies to optimise the utilisation of endoscopy resources: subjects with cumulative f-Hb concentration ≥20 µg/g faeces over two negative tests could be referred immediately for total colonoscopy (TC), while screening interval might be extended for those with undetectable f-Hb.

Patients' experience of screening CT colonography with reduced and full bowel preparation in a randomised trial.

OBJECTIVES: To assess patients' experience of bowel preparation and procedure for screening CT colonography with reduced (r-CTC) and full cathartic preparation (f-CTC) that showed similar detection rate for advanced neoplasia in a randomised trial. METHODS: Six hundred seventy-four subjects undergoing r-CTC and 612 undergoing f-CTC in the SAVE trial were asked to complete two pre-examination questionnaires-(1) Life Orientation Test - Revised (LOT-R) assessing optimism and (2) bowel preparation questionnaire-and a post-examination questionnaire evaluating overall experience of CTC screening test. Items were analysed with chi-square and t test separately and pooled. RESULTS: LOT-R was completed by 529 (78%) of r-CTC and by 462 (75%) of f-CTC participants and bowel preparation questionnaire by 531 (79%) subjects in the r-CTC group and by 465 (76%) in the f-CTC group. Post-examination questionnaire was completed by 525 (78%) subjects in the r-CTC group and by 453 (74%) in the f-CTC group. LOT-R average score was not different between r-CTC (14.27 ± 3.66) and f-CTC (14.54 ± 3.35) (p = 0.22). In bowel preparation questionnaire, 88% of r-CTC subjects reported no preparation-related symptoms as compared to 70% of f-CTC subjects (p < 0.001). No interference of bowel preparation with daily activities was reported in 80% of subjects in the r-CTC group as compared to 53% of subjects in the f-CTC group (p < 0.001). In post-examination questionnaire, average scores for discomfort of the procedure were not significantly different between r-CTC (3.53 ± 0.04) and f-CTC (3.59 ± 0.04) groups (p = 0.84). CONCLUSIONS: Reduced bowel preparation is better tolerated than full preparation for screening CT colonography. KEY POINTS: • Reduced bowel preparation is better tolerated than full preparation for screening CT colonography. • Procedure-related discomfort of screening CT colonography is not influenced by bowel preparation. • Males tolerate bowel preparation and CT colonography screening procedure better than females.

A comparison of different strategies used to invite subjects with a positive faecal occult blood test to a colonoscopy assessment. A randomised controlled trial in population-based screening programmes.

OBJECTIVE: The purpose of this parallel randomised controlled trial was to compare compliance with different modalities used to invite patients with a positive immunochemical faecal occult blood test (FIT+) for a total colonoscopy (TC). METHOD: FIT+ patients from nine Italian colorectal cancer screening programmes were randomised to be invited for a TC initially by mail or by phone and, for non-compliers, to be recalled by mail, for counselling with a general practitioner, or to meet with a specialist screening practitioner (nurse or healthcare assistant). RESULTS: In all, 3777 patients were randomised to different invitation strategies. Compliance with an initial invitation by mail and by phone was similar (86.0% vs. 84.0%, relative risk - RR: 1.02; 95%CI 0.97-1.08). Among non-responders to the initial invitation, compliance with a recall by appointment with a specialist practitioner was 50.4%, significantly higher than with a mail recall (38.1%; RR:1.33; 95%CI 1.01-1.76) or with a face-to-face counselling with the GP (30.8%; RR:1.45;95%CI 1.14-1.87). CONCLUSION: Compliance with an initial invitation for a TC by mail and by phone was similar. A personal meeting with a specialist screening practitioner was associated with the highest compliance among non-compliers with initial invitations, while the involvement of GPs in this particular activity seemed less effective.

[Screening for colorectal cancer in Italy, 2010 survey]. / Lo screening colorettale in Italia, survey 2010.

We present the main results of the 2010 survey of the Italian screening programmes for colorectal cancer carried out by the National centre for screening monitoring (Osservatorio nazionale screening, ONS) on behalf of the Ministry of health. By the end of 2010, 105 programmes were active, 9 of which had been activated during the year, and 65% of Italians aged 50-69 years were residing in areas covered by organised screening programmes (theoretical extension). Twelve regions had their whole population covered. In the South of Italy and Islands, 5 new programmes were activated in 2010, with a theoretical extension of 29%. The majority of programmes employed the faecal occult blood test (FIT), while some adopted flexible sigmoidoscopy (FS) once in a lifetime and FIT for non-responders to FS. Overall, about 3,404,000 subjects were invited to undergo FIT, 47.2% of those to be invited within the year. The adjusted attendance rate was 48% and approximately 1,568,796 subjects were screened. Large differences in the attendance rate were observed among regions: 10% of programmes reported values lower than 24%. Positivity rate of FIT programmes was 5.5% at first screening (range: 1.6-11.3%) and 4.3% at repeat screening (range: 3.2-6.7%). The average attendance rate to total colonoscopy (TC) was 81.4% and in one region it was lower than 70%. Completion rate for total colonoscopy (TC) was 88.7%. Among the 740,281 subjects attending screening for the first time, the detection rate (DR) per 1,000 screened subjects was 2.4 for invasive cancer and 10.3 for advanced adenomas (AA - adenomas with a diameter ≥1 cm, with villous/tubulo-villous type or with high-grade dysplasia). As expected, the corresponding figures in the 843,204 subjects at repeat screening were lower (1.2‰ and 7.6‰ for invasive cancer and AA, respectively). The DR of cancer and adenomas increased with age and was higher among males. Many programmes reported some difficulties in guaranteeing TC in the appropriate time frame to FIT+ subjects: in 16% of cases the waiting time was longer than two months. Nine programmes employed FS as the screening test: 98% of the target population (about 60,000 subjects) were invited, and 13,629 subjects were screened, with an attendance rate of 24%. Overall, 87% of FS were classified as complete. TC referral rate was 9.5% and the DR per 1,000 screened subjects was 2.8 and 40.6 for invasive cancer and AA, respectively.

[Methods to increase participation in cancer screening programmes]. / Metodi per aumentare la partecipazione ai programmi di screening oncologici.

OBJECTIVE: to synthesize scientific evidences about methods to increase cervical, breast and colorectal cancer screening participation. METHODS: a multidisciplinary working group has been set up to define the scope of the report and to conduct the evaluation. The scope and the final evaluation have been submitted to a stakeholder committee, including the Ministry of Health, the National Screening Observatory, regional screening program coordinators, scientific societies, and Lega Italiana Lotta ai Tumori, for comments and integrations. A systematic review of the principal biomedical and social literature databases was conducted to identify experimental and observational studies, updating the existing review by Jepson and coll. (Health Technol Assess. 2000;4(14):i-vii, 1-133). RESULTS: 5900 have been identified, 900 relevant for the topic.Among those, 148 reported quantitative information on intervention efficacy, other 90 came from the previous review. Organised screening programmes, based on invitation letter or on GP involvement,were consistently effective in increasing participation compared to spontaneous screening. Interventions are classified according to their target: individual, community, test simplification, health operators, health service organization. The report presents meta-analyses on efficacy, analyses of cost-effectiveness, impact on organisation and social inequality, and ethical and legal issues, of all the intervention reported in the literature. CONCLUSIONS: there are several interventions consistently effective in any context, some of them have minimal impact on costs and health service resources.

[The diffusion of screening programmes in Italy, year 2010]. / La diffusione dei programmi di screening in Italia, anno 2010.

The national meeting of the National Centre for Screening Monitoring (ONS) was given the title "The screening during the crisis" as we realize that the severe economical crisis of our country influences all the health policies and, as a consequence, screening programs. Within this global scenario, the results of 2010 concerning screening programs can be considered as still positive even if the gap between the North and the Central Regions as compared to the South remains. In short, in 2010 almost 9.5 millions people were invited to undergo a screening examination (3,450,000; 2,496,000 and 3,464,000 for cervical, mammographic and colorectal cancer respectively). As compared to the previous year, a large increase was observed for colorectal screening.Whereas a slight decrease was observed both for cervical and for mammographic screening. The latter trend was partially due to the overload consequent to the extension of the programme to women younger than fifty in a couple of regions (Emilia-Romagna and Piemonte). More than 4.3 millions of subjects actually complied to the invitation (1,375,000; 1,382,000 and 1,582,000 for cervical, mammographic and colorectal cancer, respectively). As a consequence of these activities were identified 6,015 breast cancers (31% of annual occurring breast cancers in Italy in the age group 50-69 years according to the most update estimates of breast cancer occurrence), 4,597 CIN2 or more severe cervical lesions, 2,916 colorectal cancers (15% of annual occurring CRC cancer in Italy in the age group 50-69 years) and 15,049 advanced adenomas.

High sensitivity of five colorectal screening programmes with faecal immunochemical test in the Veneto Region, Italy.

OBJECTIVE: Although guaiac-based faecal occult blood test screening has been shown to be effective in reducing colorectal cancer (CRC) mortality, it has been criticised mostly for its low sensitivity. Italian CRC screening programmes are based on immunochemical tests (iFOBT). We collected and analysed the interval cancers (ICs) found by five screening programmes to estimate their sensitivity. METHODS: ICs were identified in subjects who had a negative result in a screening examination from 2002 to 2007 (N=267,789); data were linked with 2002-2008 hospital discharge records. Analysis was based on the follow up of 468,306 person-years. The proportional incidence-based sensitivity was estimated overall and by sex, age class, time since last negative iFOBT result, anatomical site, and history of screening (first or subsequent test). RESULTS: Overall, 126 ICs were identified, compared to 572 expected cancers. The proportional incidences were 15.3% and 31.0% in the first and the second interval-years, respectively, with an overall episode sensitivity of 78.0% (95% CI: 73.8 to 81.6). Sensitivity was higher for males than females (80.1% vs 74.8%); no differences were observed by age, anatomical site or between programmes. The test sensitivity of iFOBT was 82.1% (95% CI 78.1% to 85.3%). CONCLUSIONS: iFOBT-based screening programmes showed a high performance in terms of sensitivity as estimated through the IC rates. The screening schedule utilised in our programmes (single iFOBT, positivity threshold of 100 ng Hb/ml of sample solution, inter-screening interval of 2 years) shows low rates of missed cancers that are diagnosed during the interval. HDR are a convenient and reliable source of data for IC studies.

Single CT colonography versus three rounds of faecal immunochemical test for population-based screening of colorectal cancer (SAVE): a randomised controlled trial.

BACKGROUND: Colorectal cancer screening is recommended for people aged 50-75 years, but the optimal screening test and strategy are not established. We aimed to compare single CT colonography versus three faecal immunochemical test (FIT) rounds for population-based screening of colorectal cancer. METHODS: This randomised controlled trial was done in Florence, Italy. Adults aged 54-65 years, never screened for colorectal cancer, were randomly assigned (1:2) by simple randomisation and invited by post to either a single CT colonography (CT colonography group) or three FIT rounds (FIT group; each round was done 2 years apart). Exclusion criteria included previous colorectal cancer, advanced adenoma, or inflammatory bowel disease, colonoscopy within the last 5 years or FIT within the last 2 years, and severe medical conditions. Participants who had a colonic mass or at least one polyp of 6 mm or more in diameter in the CT colonography group and those who had at least 20 µg haemoglobin per g faeces in the FIT group were referred for work-up optical colonoscopy. The primary outcome was detection rate for advanced neoplasia. Outcomes were assessed in the modified intention-to-screen and per-protocol populations. The trial is registered with ClinicalTrials.gov, NCT01651624. FINDINGS: From Dec 12, 2012, to March 5, 2018, 14 981 adults were randomised and invited to screening interventions. 5242 (35·0%) individuals (2809 [53·6%] women and 2433 [46·4%] men) were assigned to the CT colonography group and 9739 (65·0%) individuals (5208 [53·5%] women and 4531 [46·5%] men) were assigned to the FIT group. Participation in the screening intervention was lower in the CT colonography group (1286 [26·7%] of the 4825 eligible invitees) than it was for the FIT group (6027 [64·9%] of the 9288 eligible invitees took part in at least one screening round, 4573 [49·2%] in at least two rounds, and 3105 [33·4%] in all three rounds). The detection rate for advanced neoplasia of CT colonography was significantly lower than the detection rate after three FIT rounds (1·4% [95% CI 1·1-1·8] vs 2·0% [1·7-2·3]; p=0·0094) in the modified intention-to-screen analysis, but the detection rate was significantly higher in the CT colonography group than in the FIT group (5·2% [95% CI 4·1-6·6] vs 3·1% [2·7-3·6]; p=0·0002]) in the per-protocol analysis. Referral rate to work-up optical colonoscopy (the secondary outcome of the trial) was significantly lower for the CT colonography group than for the FIT group after three FIT rounds (2·7% [95% CI 2·2-3·1] vs 7·5% [7·0-8·1]; p<0·0001) in the modified intention-to-screen analysis, whereas no significant difference was observed in the per-protocol analysis (10·0% [8·4-11·8] vs 11·6% [10·8-12·4]). No major complications were observed in the CT colonography group after screening and work-up optical colonoscopy, whereas three cases of bleeding were reported in the FIT group after work-up optical colonoscopy (two after the first FIT and one after the second FIT). INTERPRETATION: Greater participation makes FIT more efficient than single CT colonography for detection of advanced neoplasia in population screening for colorectal cancer. Nonetheless, higher detection rate in participants and fewer work-up colonoscopies are possible advantages of CT colonography as a screening tool, which might deserve consideration in future trials. FUNDING: Government of Tuscany and Cassa di Risparmio di Firenze Foundation. TRANSLATION: For the Italian translation of the abstract see Supplementary Materials section.

Screening for colorectal cancer in Italy, 2009 survey.

We present the main results of the sixth survey of the Italian screening programmes for colorectal cancer carried out by the National centre for screening monitoring (Osservatorio nazionale screening, ONS) on behalf of the Ministry of health. By the end of 2009, 98 programmes were active, of which 13 had been activated during the year, and 59% of Italians aged 50-69 years were residing in areas covered by organised screening programmes (theoretical extension). Eleven regions had their whole population covered. In the South of Italy and Islands, 4 new programmes were activated in 2009, with a theoretical extension of 22%. The majority of programmes employ the faecal occult blood test (FOBT), while some have adopted flexible sigmoidoscopy (FS) once in a lifetime and FOBT for non-responders to FS. Overall, about 2,935,000 subjects were invited to undergo FOBT, 40% of those to be invited within the year. The adjusted attendance rate was 50% and approximately 1,426,000 subjects were screened. Large differences in the attendance rate were observed among regions, with 10% of programmes reporting values lower than 29%. Positivity rate of FOBT programmes was 5.6% at first screening (range: 2.5-12.4%) and 4.2% at repeat screening (range: 2.5-7.3%). The average attendance rate to total colonoscopy (TC) was 82.5%and in one region it was lower than 70%. Completion rate for total colonoscopy (TC) was 91.2%. Among the 631,460 subjects attending screening for the first time, the detection rate (DR) per 1,000 screened subjects was 2.4 for invasive cancer and 11.6 for advanced adenomas (AA - adenomas with a diameter ≥ 1 cm, with villous/tubulo-villous type or with high-grade dysplasia). As expected, the corresponding figures in the 824,562 subjects at repeat screening were lower (1.3‰ and 7.6‰ for invasive cancer and AA, respectively). The DR of cancer and adenomas increased with age and was higher among males. Many programmes reported some difficulties in guaranteeing TC in the appropriate time frame to FOBT+ subjects: in 16% of cases the waiting time was longer than two months. Nine programmes employed FS as the screening test: 65% of the target population (about 60,000 subjects) were invited and 9 511 subjects were screened, with an attendance rate of 24.3%. Overall, 81% of FS were classified as complete. Overall TC referral rate was 11% and the DR per 1,000 screened subjects was 2.6 and 43.7 for invasive cancer and AA, respectively.

The diffusion of screening programmes in Italy, year 2009.

In 2009, screening programmes in Italy continued to have positive results, as well as retaining some of the issues encountered in previous years. Overall, in 2009 over 9,000,000 people were invited to undergo a screening examination (3,547,000, 2,522,000 and 2,994,000, for cervical, breast, and colorectal cancer, respectively). More than 4 million people actually took up the invitation (1,393,000, 1,363,000, and 1,423,000 for cervical, breast, and colorectal cancer, respectively). The screening activities led to the finding of 5,973 breast cancers (36% of annual occurring breast cancers in Italy in the 50-69 year age group), 4 454 CIN2 or more severe cervical lesions, 2,556 colorectal cancers (16% of annual occurring CRC cancer in Italy in the 50-69 year age group), and 13,554 advanced adenomas.

Influence of seasonal variations in ambient temperatures on performance of immunochemical faecal occult blood test for colorectal cancer screening: observational study from the Florence district.

BACKGROUND: Faecal occult blood testing (FOBT) in population screening has proved to be effective in reducing mortality from colorectal cancer. In Italy a latex agglutination FOBT has been adopted for a single-sample screening programme. The aim of this study was to examine the performance of FOBTs in the Florence screening programme over several seasons to evaluate the impact of variations in ambient temperature on the performance of the screening test. METHODS: Measured haemoglobin (Hb) concentrations were aggregated into seasons with their average ambient temperature (AAT). Using logistic regression, the AAT over the period preceding the test measurement was analysed. This period included the time between faecal sampling and return of the test sample (mean 7days) and the time in the laboratory refrigerator before analysis (mean 4days). The AAT from days 5-11 before analysis of the test sample was considered a determinant of test positivity. The Kruskal-Wallis rank test was used to evaluate the significance of seasonal and/or AAT-related differences in Hb concentration. A logistic regression model adjusted for sex, age, season and screening episode (first or repeated examination) was constructed. RESULTS: 199 654 FOBT results were examined. Mean FOBT seasonal Hb concentrations (ng/ml) were: spring 27.6 (95% CI 26.2 to 29.1); summer 25.2 (95% CI 23.1 to 27.3); autumn 29.2 (95% CI 27.7 to 30.6); winter 29.5 (95% CI 27.9 to 31.1). Logistic regression showed that there was a 17% lower probability of the FOBT being positive in summer than in winter. The results of the logistic regression showed that an increase in temperature of 1°C produced a 0.7% reduction in probability of a FOBT being positive. In the summer the probability of detecting a cancer or an advanced adenoma was about 13% lower than in the winter. CONCLUSIONS: This study showed that there is a significant fall in Hb concentration at higher ambient temperatures. These results will have important implications for the organisation of immunochemical FOBT-based screening programmes, particularly in countries with high ambient temperatures.

Comparing different strategies for colorectal cancer screening in Italy: predictors of patients' participation.

OBJECTIVES: The objective of this study was to study predictors of patients' participation in colorectal cancer (CRC) screening. METHODS: Men and women, aged 55-64 years, were randomized to the following: (i) biennial fecal occult blood test (FOBT) delivered by mail (n=2,266); (ii) FOBT delivered by a general practitioner (GP)/screening facility (n=5,893); (iii) "once-only" sigmoidoscopy (FS) (n=3,650); (iv) FS followed by FOBT for screenees with negative FS (n=10,867); and (v) patient's choice between FS and FOBT (n=3,579). A stratified (by screening arm) random sample of attenders and nonattenders was contacted by trained interviewers 4 months after the initial invitation. Subjects giving their consent were administered a questionnaire (available online) investigating perceptions of individual CRC risk, attitudes toward prevention, adoption of health protective behaviors, and reasons for attendance/nonattendance. Adjusted prevalence odds ratios (ORs) were computed by multivariable logistic regression. RESULTS: The response rate was 71.9% (701 of 975) among nonattenders and 88.9% (773 of 870) among attenders. Adjusting for screening arm, center, gender, age, and education, participation was significantly higher among people who consulted their GP before undergoing screening (OR: 4.24; 95% confidence interval (CI): 3.11-5.78), who mentioned one first-degree relative with CRC (OR: 3.62; 95% CI: 2.02-6.49), who reported regular physical activity (OR: 1.85; 95% CI: 1.33-2.55), and who read the mailed information (letter only: OR: 1.85; 95% CI: 1.23-2.78; letter+leaflet: OR: 3.18; 95% CI: 2.12-4.76). People who considered screening to be ineffective (OR: 0.12; 95% CI: 0.08-0.19), those who considered it to be effective but reported even moderate levels of anxiety (OR: 0.32; 95% CI: 0.23-0.45), and those who mentioned previous knowledge of CRC screening tests were less likely to accept the invitation (OR: 0.49; 95% CI: 0.34-0.70). CONCLUSIONS: Adoption of health protective behaviors is associated with a higher attendance rate, whereas anxiety represents a strong barrier, even among people who deemed screening to be effective. Increasing the proportion of people who consult their GP when making a decision regarding screening might enhance participation.

Screening for colorectal cancer in Italy: 2008 survey.

We present the main results from the fifth survey of the Italian screening programmes for colorectal cancer carried out by the National Centre for Screening Monitoring (Osservatorio Nazionale Screening, ONS) on behalf of the Ministry of Health. By the end of 2008, 87 programmes were active (14 had been activated during the year), and 52,9%of Italians aged 50- 69 years were residing in areas covered by organised screening programmes (theoretical extension). Ten Regions had their whole population covered. In the South of Italy and Islands, 12 new programmes were activated in 2008, including those of Abruzzo and Molise Regions, with an increase of theoretical extension from 7% to 21%. The majority of programmes employ the faecal occult blood test (FOBT), while some have adopted flexible sigmoidoscopy (FS) once in a lifetime, or a combination of both. Overall, about 2,593,000 subjects were invited to undergo FOBT, 71%of those to be invited within the year. The adjusted attendance rate was 47.5% and approximately 1,171,000 subjects were screened. Large differences in the attendance rate were observed among Regions, with 10% of programmes reporting values lower than 30%. Positivity rate of FOBT programmes was 5.9% at first screening (range 2.0-11%) and 4% at repeat screening (range 2.9-6.5%). The average attendance rate for total colonoscopy (TC) was 81.3% and in three Regions it was lower than 70%. Completion rate of TC was 92.2%. Among the 665,264 subjects attending screening for the first time, the detection rate (DR) per 1,000 screened subjects was 2.7 for invasive cancer and 13.1 for advanced adenomas (AA, adenomas with a diameter ≥1 cm, with villous/ tubulo-villous type or with high-grade dysplasia). As expected, the corresponding figures in the 552,391 subjects at repeat screening were lower (1.3‰ and 8.3‰ for invasive cancer and AA, respectively). The DR of cancer and adenomas increased with age and was higher among males. Many programmes reported some difficulties in guaranteeing TC in the appropriate time frame to FOBT+ subjects: in 16.0% of cases the waiting time was longer than two months. Seven programmes employed FS as the screening test: 58.8% of the target population (about 50,000 subjects) were invited and 8,135 subjects were screened, with an attendance rate of 27.2%. Overall, 83% of FS were classified as complete. Overall TC referral rate was 13.5% and the DR per 1,000 screened subjects was 4.7 and 47.5 for invasive cancer and AA, respectively.

Cost evaluation in a colorectal cancer screening programme by faecal occult blood test in the District of Florence.

OBJECTIVES: To evaluate the direct costs of first and repeat colorectal cancer screening by immunochemical faecal occult blood testing (I-FOBT). METHODS: Florence district residents aged 50-70 were invited to undergo one-time I-FOBT every two years. Full colonoscopy was recommended for FOBT-positive subjects. Direct cost analysis was carried out separately for the first and repeat screening. All relevant resources consumed by the programme were calculated. RESULTS: Among 25,428 or 62,369 subjects invited to the first or repeat screening, respectively, the corresponding participation rate was 47.8% or 52.3%, and the positivity rate was 4.4% and 3.3%. Corresponding detection rates and positive predictive values for cancer and advanced adenoma were 11.3% or 8.9% and 32.4% or 32.8%, respectively. The assessment phase accounted for the major cost, as compared with recruitment and screening. All cost indicators were slightly higher in the first screening compared with repeat screening. Cost per cancer and advanced adenoma detected was similar in the first or repeat screening. A higher than observed participation rate would have substantially reduced screening cost. CONCLUSION: Analysis of I-FOBT-organized population-based screening cost demonstrates lower cost at repeat compared with first screening and provides reference for decision-making in screening implementation.

Screening for colorectal cancer in Italy: 2006 survey.

We present the main results of the third survey of the Italian screening programmes for colorectal cancer carried out by the ONS (Osservatorio Nazionale Screening, National Centre for Screening Monitoring) on behalf of the Ministry of Health. During 2006, many new programmes were activated and by the end of the year, 44% of Italians aged 50-69 years were residing in areas covered by organised screening programmes (theoretical extension). Five regions had their entire population covered. In the South of Italy and Islands only one new programme was activated in 2006, with a 10% theoretical extension. The majority of programmes employ the faecal occult blood test (FOBT), while some have adopted the flexible sigmoidoscopy (PS) once in a lifetime, or a combination of both. Overall, about 2,107,000 subjects were invited to undergo FOBT, 70.3% of those to be invited within the year. The adjusted attendance rate was 44.6% and approximately 907,000 subjects were screened. Major differences in the attendance rate were observed among regions, with 10% of programmes reporting values lower than 26%. Positivity rate of FOBT programmes was 5.3% at first and 3.9% at repeat screening: it increased with age and was higher among males than females in all age groups. The average attendance rate to total colonoscopy (TC) was 81% (10th-9Oth percentiles: 64%, 93%). Completion rate of TC was 89%, with higher rates among males. At first screening, the detection rate (DR) per 1,000 screened subjects was 3.1 and 14.6 for invasive cancer and advanced adenomas (AA--adenomas with a diameter > or =1 cm, with villous/tubulo-villous type or with high-grade dysplasia), respectively; the corresponding figures at repeat screening were 1.3 per thousand for cancer and 7.7 per thousand for AA. The DR of cancer and adenomas increased with age and was higher among males; 25% of screen-detected cancers were in TNM stage III+. The positive predictive value (PPV) was 6.8% for cancer and 32.1% for AA at first screening, and 4.0% for cancer and 23.4% for AA at repeat screening. Given the high PPVof a positive FOBT, obtaining a high attendance at TC is therefore crucial. Seven programmes employed PS as the screening test: 51.4% of the target population (about 50,000 subjects) were invited and 7,589 subjects were screened, with an attendance rate of 29.2%. Overall, 88% of FS were classified as complete. TC referral rates ranged between 6.1 and 17.8%, due to different referral criteria. Among subjects referred to colonoscopy, the prevalence of proximal AA and cancer ranged from 6 to 18.2%. The overall DR (subjects with at least one advanced lesion) ranged from 4.9 to 7.5%. In conclusion, during 2006, organised colorectal cancer screening programmes in Italy grew considerably, covering almost half of the eligible population at a national level. Many programmes were activated in the second part of the year, thus their results should be evaluated with caution. However, reported experiences showed good results in terms of attendance and DR, although some critical aspects need to be carefully addressed when planning and implementing screening activity.

Faecal immunochemical test in subjects not attending screening computed tomography colonography and colonoscopy in a randomized trial.

The aim of this study was to evaluate the participation and yield of the faecal immunochemical test (FIT) in nonattendees for computed tomography colonography (CTC) or optical colonoscopy (OC) screening, in the setting of a randomized trial. In the SAVE trial, 16087 individuals were randomly assigned and invited to one of four interventions for colorectal cancer screening: (i) biennial FIT for three rounds; (ii) reduced-preparation CTC; (iii) full-preparation CTC; and (iv) OC. Nonattendees of reduced-preparation CTC, full-preparation CTC and OC groups were invited to FIT. Here, we analysed the participation rate and the detection rate for cancer or advanced adenoma (advanced neoplasia) of FIT among nonattendees for reduced-preparation CTC, full-preparation CTC and OC. Nonattendees were 1721 of 2395 (71.9%) eligible invitees in the reduced-preparation CTC group, 1818 of 2430 (74.8%) in the full-preparation CTC group and 883 of 1036 (85.2%) in the OC group. Participation rates for FIT were 20.2% (347/1721) in nonattendees for reduced-preparation CTC, 21.4% (389/1818) in nonattendees for full-preparation CTC and 25.8% (228/883) in nonattendees for OC. Differences between both CTC groups and the OC group were statistically significant (P≤0.01), whereas the difference between reduced-preparation and full-preparation CTC groups was not statistically significant (P=0.38). The detection rate of FIT was not statistically significantly different among nonattendees for reduced-preparation CTC (0.9%; 3/347), nonattendees for full-preparation CTC (1.8%; 7/389) and nonattendees for OC (1.3%; 3/228) (P>0.05). Offering FIT to nonattendees for CTC or OC increases the overall participation in colorectal cancer screening and enables the detection of additional advanced neoplasia.

Cost analysis of colorectal cancer screening with CT colonography in Italy.

OBJECTIVE: Unit costs of screening CT colonography (CTC) can be useful for cost-effectiveness analyses and for health care decision-making. We evaluated the unit costs of CTC as a primary screening test for colorectal cancer in the setting of a randomized trial in Italy. METHODS: Data were collected within the randomized SAVE trial. Subjects were invited to screening CTC by mail and requested to have a pre-examination consultation. CTCs were performed with 64- and 128-slice CT scanners after reduced or full bowel preparation. Activity-based costing was used to determine unit costs per-process, per-participant to screening CTC, and per-subject with advanced neoplasia. RESULTS: Among 5242 subjects invited to undergo screening CTC, 1312 had pre-examination consultation and 1286 ultimately underwent CTC. Among 129 subjects with a positive CTC, 126 underwent assessment colonoscopy and 67 were ultimately diagnosed with advanced neoplasia (i.e., cancer or advanced adenoma). Cost per-participant of the entire screening CTC pathway was €196.80. Average cost per-participant for the screening invitation process was €17.04 and €9.45 for the pre-examination consultation process. Average cost per-participant of the CTC execution and reading process was €146.08 and of the diagnostic assessment colonoscopy process was €24.23. Average cost per-subject with advanced neoplasia was €3777.30. CONCLUSIONS: Cost of screening CTC was €196.80 per-participant. Our data suggest that the more relevant cost of screening CTC, amenable of intervention, is related to CTC execution and reading process.

[Ouality indicators for the evaluation of colorectal cancer screening programmes]. / Indicatori di qualità per la valutazione dei programmi di screening dei tumori colorettali.

Colorectal cancer screening programmes, which are supported by national and international recommendations, are gradually developing andspreading throughout Italy. The programmes strive to guarantee maximum equality, improve quality of life, and inform the target population about benefits and possible risks. These goals can only be achieved with adequate planning and training for the staff involved. Moreover, it is essential to regularly verify the quality of each step of the process, with a system that can constantly monitor the parameters used for the evaluation of quality and efficacy. The present document, created by the Italian Group for Colorectal Screening (GISCoR), proposes a unified method for collecting and reporting screening data using commonly agreed terminology, definitions and classifications, thus making it possible to compare data with standards and data from other programmes, and to plan suitable interventions. The indicators considered refer to the entire screening process, including organisational, logistic and performance indicators. The indicators are provided in the form of concise and easy-to-use data sheets. Every data sheet contains briefsections: definition of the indicator, goal, the data necessary to build it, the formula required to build it, possible problems of interpretation, acceptable and desirable standards.

Screening for colorectal cancer in Italy: 2005 survey.

We present the main results from the second survey of the Italian screening programmes for colorectal cancer carried out by the National Centre for Screening Monitoring on behalf of the Ministry of Health. During 2005, 52 programmes, adopting faecal occult blood testing (FOBT), sigmoidoscopy (FS), or a combination of both, were active in Italy. Overall, 827,473 subjects were invited to FOBT and 376,240 were screened; the adjusted attendance rate (47.1%) equals the best performances reported in the literature. Positivity rate of FOBT programmes was 5.8% at first and 4.1% at repeat screening: it increased with age and was higher among males than females in all age groups. The average attendance rate to colonoscopy (TC) was 82% (range: 56%-100%). Completion rate of TC was 91%, with higher rates among males. At first screening, the detection rate (DR) per 1000 screened subjects was 3.7 and 16.8 for invasive cancer and advanced adenomas (AA) (adenomas with a diameter > or =1 cm, with villous/tubulo-villous type or with high-grade dysplasia) respectively; the corresponding figures at repeat screening were 1.1 for cancer and 4.9 for AA. The DR of cancer and adenomas increased with age and it was higher among males, 55% of screen-detected cancers were at TNM stage I. The positive predictive value (PPV) was 7.4% for cancer and 32.9% for AA at first screening, and 4.5% for cancer and 20.5% for AA at repeat screening. Given this high PPV of positive FOBT, to obtain a high attendance at TC is crucial. The six FS programmes invited almost half of their target population (about 40,000 subjects) and 5,821 subjects were screened, with an attendance rate of 29.1%. Overall 89.0% of FS were classified as complete. TC referral rates ranged between 7.7 and 13.8%, due to different referral criteria. Among subjects referred to colonoscopy the prevalence of proximal AA and cancer ranged from 5.4 to 11.1%. The overall DR (subjects with at least one advanced lesion) ranged from 3.5 to 7.0%. In conclusion, during 2005 the organised programmes for colorectal cancer screening in Italy increased considerably, covering about one third of the eligible population at a national level. Many programmes were activated in the second part of the year, thus their results have to be evaluated with caution. However, the reported experiences showed good results in terms of attendance and DR, although some critical aspects need to be carefully addressed when planning and implementing screening activity.